EP1227851B1 - Materiau d'implant osseux resorbable et son procede de production - Google Patents

Materiau d'implant osseux resorbable et son procede de production Download PDF

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Publication number
EP1227851B1
EP1227851B1 EP00975867A EP00975867A EP1227851B1 EP 1227851 B1 EP1227851 B1 EP 1227851B1 EP 00975867 A EP00975867 A EP 00975867A EP 00975867 A EP00975867 A EP 00975867A EP 1227851 B1 EP1227851 B1 EP 1227851B1
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EP
European Patent Office
Prior art keywords
implant material
material according
powder
calcium sulfate
implant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP00975867A
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German (de)
English (en)
Other versions
EP1227851A1 (fr
Inventor
Helmut Wahlig
Elvira Dingeldein
Edgar WÜST
Christoph Sattig
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Coripharm Medizinprodukte GmbH and Co KG
Original Assignee
Coripharm Medizinprodukte GmbH and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Publication of EP1227851A1 publication Critical patent/EP1227851A1/fr
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Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/0047—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L24/0052—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with an inorganic matrix
    • A61L24/0063—Phosphorus containing materials, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A61L24/0042—Materials resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/42—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L27/425—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of phosphorus containing material, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30677—Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00179—Ceramics or ceramic-like structures
    • A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • bone replacement materials especially in in the areas of orthopedics, traumatology, skull, jaw and facial surgery, as well as ododontology is still taking to.
  • the material used according to the invention is a hydroxyapatite which, in contrast to all the hydroxyapatite materials previously used as implants, is not subjected to a sintering process, but is produced synthetically by a precipitation process.
  • the material obtained in this way is further characterized in that, owing to the special production process, it is absolutely pure and is present in the form of tiny crystals (so-called nano-particles).
  • the crystal size of this material is 10-20 nm wide and 50-60 nm long, which is very close to the size of the apatite crystals in human bones of 5-10 nm.
  • the specific absorbing BET surface area of the nano-crystals is approx. 100-150 m 2 / g.

Abstract

L'invention concerne un matériau d'implant osseux résorbable, préparé à partir d'un constituant pulvérulent contenant de l'hydroxyapatite et à partir de liquide. Le constituant pulvérulent du matériau d'implant comprend pratiquement un mélange de poudre d'hydroxyapatite et de poudre de sulfate de calcium, la poudre d'hydroxyapatite étant composée de nanoparticules cristallines précipitées synthétiques très pures, ayant une taille de cristaux de largeur comprise entre 10 et 20 nm et de longueur comprise entre 50 et 60 nm. La surface BET absorbante spécifique des nanocristaux est de préférence comprise entre 100 et 150 m2/g.

Claims (27)

  1. Matériau d'implant osseux résorbable préparé à partir d'un constituant en poudre contenant de l'hydroxylapatite et de liquide,
    caractérisé par le fait    que le constituant en poudre est constitué essentiellement d'un mélange de poudre d'hydroxylapatite et de poudre de sulfate de calcium, et
       que la poudre d'hydroxylapatite est constituée de nanoparticules cristallines de haute pureté précipitées produites par synthèse et ses cristaux ont de 10 à 20 nm de large et de 50 à 60 nm de long.
  2. Matériau d'implant selon la revendication 1, caractérisé par le fait que l'aire massique BET absorbante des nanocristaux est de 100 à 150 m2/g.
  3. Matériau d'implant selon l'une des revendications 1 et 2, caractérisé par le fait que la poudre de sulfate de calcium est constituée d'un sous-hydrate alpha (bassanite) de haute pureté produit par synthèse à n molécule d'eau (n étant inférieur à 1 et valant environ 0,5).
  4. Matériau d'implant selon la revendication 3, caractérisé par le fait que l'aire massique BET absorbante des particules de sulfate de calcium est de 1,8 à 2,7 m2/g et de préférence de 2,0 à 2,3 m2/g.
  5. Matériau d'implant selon l'une des revendications 3 et 4, caractérisé par le fait que la poudre de sulfate de calcium contient en plus de 2 à 15 % en poids, de préférence de 5 à 10 % en poids, d'oxyde de calcium.
  6. Matériau d'implant selon l'une des revendications 1 à 5, caractérisé par le fait que le rapport des aires massiques BET du mélange de nanoparticules d'apatite et de particules de sulfate de calcium est d'environ 150/2.
  7. Matériau d'implant selon l'une des revendications 1 à 6, caractérisé par le fait que la proportion de poudre d'hydroxylapatite dans le constituant en poudre est de 85 à 55 % en poids, de préférence de 80 à 70 % en poids.
  8. Matériau d'implant selon l'une des revendications 1 à 7, caractérisé par le fait que le constituant en poudre est, avant sa préparation, stérilisé par rayonnement β ou γ.
  9. Matériau d'implant selon la revendication 8, caractérisé par le fait que le constituant en poudre stérile est transformé avec de l'eau stérile en une matière d'abord visqueuse et ensuite se solidifiant.
  10. Matériau d'implant selon la revendication 9, caractérisé par le fait que la proportion d'eau stérile pour la préparation de la matière visqueuse est de 100 à 200 % en poids par rapport au poids du constituant en poudre.
  11. Matériau d'implant selon l'une des revendications 9 et 10, caractérisé par le fait que la matière visqueuse présente un pH légèrement alcalin compris entre 7,5 et 8,2.
  12. Matériau d'implant selon l'une des revendications de 9 à 11, caractérisé par le fait que la matière présente après préparation une consistance plastique fluide.
  13. Matériau d'implant selon l'une des revendications 1 à 7, caractérisé par le fait qu'il se présente sous forme de granulés de différentes grosseurs de grain ou de corps moulés, en particulier de sphères, cylindres, prismes ou parallélépipèdes rectangles de différentes dimensions.
  14. Matériau d'implant selon la revendication 13, caractérisé par le fait que le constituant en poudre est préparé avec 100 à 200 % en poids d'eau distillée par rapport à son poids et solidifié dans des moules.
  15. Matériau d'implant selon la revendication 14, caractérisé par le fait que la matière solidifiée dans les moules est broyée à une consistance de granulé.
  16. Matériau d'implant selon l'une des revendications 13 à 15, caractérisé par le fait qu'il est ajusté à une capacité d'absorption d'eau reproductible normalisée.
  17. Matériau d'implant selon l'une des revendications 13 à 16, caractérisé par le fait que les corps moulés sont, après leur durcissement, stérilisés par irradiation aux rayons β ou γ ou par gazage à l'oxyde d'éthylène et empaquetés de manière stérile.
  18. Matériau d'implant selon l'une des revendications 13 à 17, caractérisé par le fait que les corps moulés sont, avant application, imprégnés de solutions d'agents pharmaceutiques stériles.
  19. Matériau d'implant selon la revendication 18, caractérisé par le fait que comme solutions d'agents sont prévus des antibiotiques ou des facteurs de croissance préparés à l'état liquide.
  20. Matériau d'implant selon l'une des revendications 18 et 19, caractérisé par le fait que les corps moulés sont imprégnés en combinaison de plusieurs solutions d'agents différentes.
  21. Procédé de production d'un matériau d'implant osseux à partir d'un constituant en poudre contenant de l'hydroxylapatite avec de l'eau,
    caractérisé par le fait    que le constituant en poudre est produit par mélange de 85 à 55 % en poids de poudre d'hydroxylapatite constituée de nanoparticules précipitées produites par synthèse d'hydroxylapatite de haute pureté à des cristaux de 10 à 20 nm de large et de 50 à 60 nm de long avec 15 à 45 % en poids de poudre de sulfate de calcium sous forme de sous-hydrate α de haute pureté à n molécule d'eau (n étant inférieur à 1 et d'environ 0,5), et le mélange de poudres ainsi obtenu est transformé avec 100 à 200 % en poids d'eau stérile en une matière d'abord visqueuse qui ensuite se solidifie en un corps.
  22. Procédé selon la revendication 21, caractérisé par le fait qu'à la poudre de sulfate de calcium sont ajoutés, avant ou pendant le mélange avec la poudre d'hydroxylapatite, de 5 à 10 % en poids d'oxyde de calcium en poudre.
  23. Procédé selon l'une des revendications 21 et 22, caractérisé par le fait que le constituant en poudre est, avant sa préparation, stérilisé par irradiation aux rayons β ou γ.
  24. Procédé selon l'une des revendications 21 à 23, caractérisé par le fait que la matière préparée d'abord visqueuse est mise dans des moules, y est solidifiée et en est ensuite enlevée sous forme de corps moulés en morceaux.
  25. Procédé selon la revendication 24, caractérisé par le fait que les corps moulés sont stérilisés par irradiation aux rayons β ou γ ou par gazage à l'oxyde d'éthylène et ensuite empaquetés de manière stérile.
  26. Procédé selon l'une des revendications 24 et 25, caractérisé par le fait que les corps moulés stériles sont, avant application, imprégnés d'une solution d'agent pharmaceutique.
  27. Procédé selon l'une des revendications 24 et 25, caractérisé par le fait que les corps moulés stériles sont, avant application, imprégnés d'une combinaison de plusieurs solutions d'agents pharmaceutiques contenant des agents différents.
EP00975867A 1999-11-09 2000-10-14 Materiau d'implant osseux resorbable et son procede de production Expired - Lifetime EP1227851B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19953771 1999-11-09
DE19953771A DE19953771C1 (de) 1999-11-09 1999-11-09 Resorbierbares Knochen-Implantatmaterial sowie Verfahren zur Herstellung desselben
PCT/EP2000/010133 WO2001034216A1 (fr) 1999-11-09 2000-10-14 Materiau d'implant osseux resorbable et son procede de production

Publications (2)

Publication Number Publication Date
EP1227851A1 EP1227851A1 (fr) 2002-08-07
EP1227851B1 true EP1227851B1 (fr) 2003-05-07

Family

ID=7928360

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00975867A Expired - Lifetime EP1227851B1 (fr) 1999-11-09 2000-10-14 Materiau d'implant osseux resorbable et son procede de production

Country Status (6)

Country Link
US (1) US6689375B1 (fr)
EP (1) EP1227851B1 (fr)
JP (1) JP2003513711A (fr)
DE (2) DE19953771C1 (fr)
ES (1) ES2199185T3 (fr)
WO (1) WO2001034216A1 (fr)

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US9144631B2 (en) 2003-01-27 2015-09-29 Benedicte Asius Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof

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DE19953771C1 (de) 2001-06-13
WO2001034216A1 (fr) 2001-05-17
DE50002122D1 (de) 2003-06-12

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